{"abstract":"The Food and Drug Administration (FDA or we) is classifying the hemostatic device for intraluminal gastrointestinal use into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the hemostatic device for intraluminal gastrointestinal use's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.","action":"Final order.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2018/10/19/2018-22784.html","cfr_references":[{"chapter":null,"citation_url":null,"part":878,"title":21}],"citation":"83 FR 52970","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This order is effective October 19, 2018. The classification was applicable on May 7, 2018.","disposition_notes":null,"docket_ids":["Docket No. FDA-2018-N-3595"],"dockets":[],"document_number":"2018-22784","effective_on":"2018-10-19","end_page":52972,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2018/10/19/2018-22784.xml","html_url":"https://www.federalregister.gov/documents/2018/10/19/2018-22784/medical-devices-general-and-plastic-surgery-devices-classification-of-the-hemostatic-device-for","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2018-22784?publication_date=2018-10-19","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2018-10-19/2018-22784/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":709,"last_updated":"2026-09-22 06:15:08 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2018-10-19/pdf/2018-22784.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2018-22784.pdf?1539866725","publication_date":"2018-10-19","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2018/10/19/2018-22784.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2018-N-3595","supporting_documents_count":0,"docket_id":"FDA-2018-N-3595","regulation_id_number":null,"title":"Medical Devices; General and Plastic Surgery Devices; Classification of the Hemostatic Device for Intraluminal Gastrointestinal Use","checked_regulationsdotgov_at":"2018-11-08T11:00:33Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":52970,"subtype":null,"title":"Medical Devices; General and Plastic Surgery Devices; Classification of the Hemostatic Device for Intraluminal Gastrointestinal Use","toc_doc":"General and Plastic Surgery Devices; Classification of the Hemostatic Device for Intraluminal Gastrointestinal Use","toc_subject":"Medical Devices:","topics":["Medical devices"],"type":"Rule","volume":83}